CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tasimelteon (Hetlioz) — Non-24 and Smith-Magenis syndrome nighttime sleep disturbances

Covers medical necessity criteria, authorization limits, and quantity limits for tasimelteon capsules and Hetlioz oral suspension for treatment of Non-24-Hour Sleep-Wake Disorder and nighttime sleep disturbances in Smith-Magenis syndrome for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTasimelteon (Hetlioz) — Non-24 and Smith-Magenis syndrome nighttime sleep disturbances

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2018

Next Review DateMar 1, 2026

Key ActionSubmit prior authorization with documentation of diagnosis and prescriber specialty for a 6-month approval when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauthorization duration

1/daycapsule quantity limit

5 ml/dayoral suspension limit

3-15oral suspension age

total blindnessNon-24 diagnosis

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Coverage Criteria

Non-24-Hour Sleep-Wake Disorder (Adults)

Covered when ALL of the following are met:

Non-24 criteria: a) The requested drug is prescribed by, or in consultation with, a sleep specialist or psychiatrist; b) Documentation that the member has a diagnosis of total blindness in both eyes (e.g., nonfunctioning retinas); c) Documentation that the member is NOT able to perceive light in either eye; d) Documentation that the member is experiencing difficulty initiating sleep, difficulty awakening in the morning, excessive daytime sleepiness, or increased total nighttime sleep and/or decreased daytime nap duration; e) The request is for tasimelteon capsules.

Authorization of 6 months may be granted.

Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS)

Covered when ALL of the following are met:

SMS initial criteria: a) The requested drug is prescribed by, or in consultation with, a sleep specialist or psychiatrist; b) Documentation that the member has a diagnosis of Smith-Magenis syndrome with genetic test results confirming either a heterozygous deletion of 17p11.2 OR a heterozygous pathogenic variant involving RAI1; c) Documentation that the member has a history of sleep disturbances; d) If requesting oral suspension, member must be between the ages of 3 and 15 years old.

Authorization of 6 months may be granted.

SMS continuation criteria: Documentation of improvement in the quality of sleep since starting Hetlioz is required for continued authorization.

Listed specifically for continuation.

All indications for tasimelteon (Hetlioz) other than the FDA‑approved uses for Non‑24‑Hour Sleep‑Wake Disorder (Non‑24) in adults and nighttime sleep disturbances in Smith‑Magenis syndrome (SMS) are considered experimental/investigational and are not a covered benefit.

Use of tasimelteon for indications other than Non‑24 or SMS is considered not medically necessary/experimental and is not a covered benefit.

Coding, Formulations & Authorization Limits

Covered formulations and quantity limitsmixedCovered

tasimelteon 20 mg capsule	Tasimelteon 20mg capsule — quantity limit 1 capsule per day
Hetlioz oral suspension 4 mg/ml	Hetlioz 4mg/ml oral suspension — quantity limit 5 ml per day

Covered formulations and quantity limits (alternate phrasing)mixedCovered

Tasimelteon 20mg capsule	1 capsule per day
Hetlioz 4mg/ml oral suspension	5 ml per day

Authorization duration

Standard initial authorization duration6 months

Applies when criteria met for Non-24 or SMSPrior authorization may be granted for 6 months when the specific clinical criteria are met and documentation provided

Applies to requested formulationRequest must specify formulation (capsule vs oral suspension) as relevant to indication

Provider Actions and Requirements

Prior Authorization

Prior authorization: 6-month approvals when criteria met

Prior authorization may be granted for an initial 6-month period when all applicable clinical criteria for Non-24 or SMS are met; requests must specify the formulation (capsule vs oral suspension) and be prescribed by or in consultation with a sleep specialist or psychiatrist.

Authorization of 6 months may be granted when criteria are met
Requests must specify formulation (capsule or oral suspension)
Prescribed by or in consultation with a sleep specialist or psychiatrist

Step Therapy

Step therapy

No step therapy or prerequisite medication trials are specified in this policy for tasimelteon or Hetlioz.

Background

Tasimelteon (marketed as Hetlioz) is FDA‑approved for two distinct indications: treatment of Non‑24‑Hour Sleep‑Wake Disorder (Non‑24) with capsules in adults, and treatment of nighttime sleep disturbances in Smith‑Magenis syndrome (SMS) — with capsules for patients 16 years and older and with Hetlioz oral suspension for pediatric patients aged 3–15 years. All other uses are considered experimental/investigational and are not covered.

Definitions

Non-24-Hour Sleep-Wake Disorder (Non-24)

DefinitionA circadian rhythm disorder primarily affecting totally blind individuals who cannot perceive light in either eye, leading to difficulty initiating sleep, difficulty awakening, or excessive daytime sleepiness

Typical patient populationAdults with total blindness in both eyes (nonfunctioning retinas) who are unable to perceive light

Clinical documentation requiredDocumentation of total blindness in both eyes and inability to perceive light must be provided for authorization

Formulation applicableTreatment requests must be for tasimelteon capsules for Non-24

Smith-Magenis syndrome (SMS) nighttime sleep disturbances

DefinitionNighttime sleep disturbances associated with Smith-Magenis syndrome (SMS), a genetic disorder confirmed by specific genetic test results

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTasimelteon (Hetlioz) — Non-24 and Smith-Magenis syndrome nighttime sleep disturbances

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2018

Next Review DateMar 1, 2026

Key ActionSubmit prior authorization with documentation of diagnosis and prescriber specialty for a 6-month approval when criteria are met.

SourceLink

On This Page

Documentation Required

Required clinical documentation

Provide documentation supporting the requested indication, including diagnostic confirmation and symptom history; include prescriber specialty when applicable.

For Non-24: documentation of total blindness in both eyes (e.g., nonfunctioning retinas) and that the member cannot perceive light in either eye; documentation of symptoms such as difficulty initiating sleep, difficulty awakening, or excessive daytime sleepiness (or increased total nighttime sleep/decreased daytime naps) (chunk 2, 5).
For SMS: documentation of Smith-Magenis syndrome with genetic test results confirming a heterozygous 17p11.2 deletion OR a heterozygous pathogenic RAI1 variant, and history of sleep disturbances (chunks 3, 4, 6).
If oral suspension is requested for SMS, include patient's age to confirm 3–15 years (chunks 4, 6).
If prescribed by a non-specialist, include consultation or prescription from a sleep specialist or psychiatrist (chunk 2, 3).

Denial Risk

Non-covered indications

Requests for use of tasimelteon for any indication other than the FDA‑approved indications (Non-24 in adults and nighttime sleep disturbances in SMS) are considered experimental/investigational and are not covered.

Genetic confirmation requirementsGenetic test results must confirm either a heterozygous deletion of 17p11.2 OR a heterozygous pathogenic variant involving RAI1

Age and formulation notesTasimelteon capsules indicated for patients ≥16 years; Hetlioz oral suspension indicated for pediatric patients 3–15 years (authorization requires age documentation when oral suspension requested)

Continuation requirementFor continued authorization, documentation of improvement in sleep quality since starting Hetlioz is required (for SMS)